Table 1. Baseline Characteristics of the Trial Participantsa.
| Characteristic | Best medical treatment (n = 49) | RYGB (n = 51) |
|---|---|---|
| Age, mean (SD), y | 50.2 (7.5) | 52.5 (7.6) |
| Diabetes duration, median (IQR), y | 9 (5-13) | 10 (6-12) |
| Males | 27 (55) | 28 (55) |
| Race/ethnicityb | ||
| White | 34 (69) | 46 (90) |
| Black | 2 (4) | 0 |
| Asian | 3 (6) | 1 (2) |
| Mixed | 8 (16) | 4 (8) |
| Undeclared | 2 (4) | 0 |
| Waist circumference, mean (SD), cm | 111.1 (8.1) | 112.2 (8.01) |
| BMI, mean (SD) | 32.6 (2.1) | 32.5 (1.9) |
| Creatinine level, median (IQR), mg/dL | 0.80 (0.65-0.95) | 0.78 (0.64-0.98) |
| Urinary creatinine level, median (IQR), mg/dL | 0.95 (0.64-1.12) | 0.95 (0.71-1.33) |
| Urinary albumin to creatinine ratio, median (IQR), mg/g | 73 (52-168) | 72 (53-143) |
| eGFR, mean (SD), mL/min/1.73 m2 | 96.18 (21.41) | 94.59 (16.17) |
| Retinopathy status | ||
| Not available or undetermined | 6 (12) | 3 (6) |
| None | 29 (59) | 31 (61) |
| NPDR | 9 (18) | 11 (22) |
| PDR | 5 (10) | 6 (12) |
| Neuropathy status | ||
| Not available | 1 (2) | 3 (6) |
| None | 25 (51) | 25 (49) |
| Any | 23 (47) | 23 (45) |
| Glycemia | ||
| HbA1c level, mean (SD), % | 8.94 (1.96) | 8.80 (1.86) |
| Fasting plasma glucose level, mean (SD), mg/dL | 174 (142-232) | 167 (145-208) |
| Lipid levels, mean (SD), mg/dL | ||
| Total cholesterol | 192.8 (46.6) | 185.2 (38.4) |
| HDL-C | 39.0 (11.4) | 41.1 (12.4) |
| LDL-C | 108.6 (41.1) | 102 (36.5) |
| Proportion of patients with LDL-C level <100 mg/dL | 22 (45) | 24 (47) |
| Triglyceride levels, median (IQR), mg/dL | 214 (150-334) | 195 (145-293) |
| Blood pressure, mean (SD), mm Hg | ||
| Systolic | 137.3 (15.5) | 141.5 (17.2) |
| Diastolic | 85.7 (8.0) | 88.1 (12.7) |
| Medications | ||
| Biguanides | 45 (92) | 40 (78) |
| Thiazolidinediones | 4 (8) | 2 (4) |
| GLP-1 analog or receptor agonists | 13 (26) | 23 (45) |
| SGLT2 inhibitors | 2 (4) | 2 (4) |
| Secretagogues | 20 (41) | 21 (41) |
| Insulin | 12 (24.) | 20 (39) |
| Lipid-lowering agentsc | 18 (37) | 30 (59) |
| β-blockers | 6 (12) | 8 (16) |
| Calcium channel blockers | 7 (14) | 13 (26) |
| ACE inhibitors or ARBs | 30 (61) | 37 (72) |
| Diuretics | 17 (35) | 15 (29) |
| Anticoagulants | 16 (33) | 17 (33) |
Abbreviations: ACE, angiotensin-converting enzyme; ARB, angiotensin receptor blocker; BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); eGFR, estimated glomerular filtration rate; GLP-1, glucagonlike peptide 1; HbA1c, glycated hemoglobin; HDL-C, high-density lipoprotein cholesterol; IQR, interquartile range; LDL-C, low-density lipoprotein cholesterol; NPDR, nonproliferative diabetic retinopathy; PDR, proliferative diabetic retinopathy; RYGB, Roux-en-Y gastric bypass; SGLT2, sodium coupled glucose transporter 2.
SI conversion factors: To convert creatinine to micromoles per liter, multiply by 88.4; to convert total cholesterol, HDL-C, and LDL-C to millimoles per liter, multiply by 0.0259; to convert HbA1c to proportion of total hemoglobin, multiply by 0.01; to convert glucose, to millimoles per liter, multiply by 0.0555; to convert triglycerides to millimoles per liter, multiply by 0.0113.
Data are presented as number (percentage) of participants unless otherwise indicated.
Race/ethnicity was self-reported.
P = .03. All other comparisons were not statistically significant.